Sanofi CEO: Arthritis med ‘long shot’ in COVID-19; study results ‘imminent’

• Sanofi anticipates study results for an arthritis drug repurposed to treat COVID-19 will be available “imminently,” said Paul Hudson, CEO of the French drugmaker, which along with Regeneron is testing the immune-blocking therapy Kevzara in two clinical trials.
• The companies hope Kevzara could play a role in easing the severe respiratory symptoms some patients with coronavirus disease experience. But Hudson cautioned against expecting too much, describing it on a Friday conference call as a “fingers-crossed situation.”
• Still, Hudson said Sanofi has taken its Kevzara drug production “to the maximum” in case the trials show the drug benefits COVID-19 patients. Fellow large pharma Roche, which is testing in COVID-19 a drug that works the same way as Kevzara, is taking a similar approach while its own late-stage study progresses.

Repurposing existing drugs for a new disease is a tantalizing opportunity, particularly now, when doctors and hospitals the world over are desperate to quickly find any treatment to work against COVID-19.
But it’s not necessarily a high-probability approach, even if preliminary testing suggests a plausible scientific hypothesis.
“Trying medicines that are previously approved for different indications is always going to be a little bit serendipitous,” said Sanofi’s Hudson, while discussing the COVID-19 studies his company is running with Kevzara.
Approved to treat rheumatoid arthritis, Kevzara blocks an inflammatory protein known as interluekin-6, or IL-6. Tamping that down with Kevzara, or other drugs like it, helps to curb the painful inflammation people with rheumatoid arthritis experience.
But inhibiting IL-6 is also proven to calm an immune system pushed into overdrive following treatment with cancer cell therapy.
Studies of COVID-19 patients have shown that, in some, levels of IL-6 and other related inflammatory proteins are particularly high during the acute respiratory distress that characterizes severe cases, raising hopes that IL-6 inhibitors could prove beneficial.
One early test in China found Actemra, an anti-IL-6 drug made by Roche, reduced the need for oxygen in 15 of 20 COVID-19 patients and lowered inflammatory markers in 16.
The studies run by Sanofi and Regeneron, as well as a Phase 3 trial led by Roche, aim to show a similar result on a larger scale.
“Whilst it’s a long shot, it’s the very least we can do to try to follow the biology and other experiences across the world from investigators,” said Sanofi’s Hudson on Friday.
“It’s a fingers-crossed situation, and I’m sure it is for all the IL-6 manufacturers to try and work out what we can do. We’re just waiting for the evidence,” he added later in the conference call, held to announce Sanofi’s first quarter earnings.
That evidence, or at least a first cut of it, should come soon — “imminently” for Sanofi and Regeneron, and by June for Roche.
Sanofi and Regeneron’s trials, run in Europe and the U.S., respectively, were set up as two-stage studies, with the first part testing whether the drugs can reduce fever or one specific inflammatory marker. The Phase 3 portion will assess whether patients improved clinically, as measured by a seven-point scale.
Each are enrolling several hundred patients, according to listings on the federal database clinicaltrials.gov.
Other drugmakers have focused on the fierce immune response seen in COVID-19, too, exploring whether cancer drugs like AstraZeneca’s Calquence or Novartis and Incyte’s Jakafi can help.
Much of the recent focus, however, has been on the antiviral remdesivir, developed by Gilead and now in a number of major late-stage studies. Some data has recently emerged via leaked presentations and postings made online, but those snapshots have been difficult to decipher.
Gilead has said it expects to report data from its first trial, in severe COVID-19 patients, by the end of this month.
https://www.biopharmadive.com/news/coronavirus-sanofi-kevzara-study-results-imminent/576733/